Auditory Brainstem Implant (ABI) in Children With No Cochleae or Auditory Nerves

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT02310399
Status
Recruiting
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Conditions

  • Hearing Loss, Bilateral (Causes Other Than Tumors)

Eligibility Criteria

Sex
ALL
Age
18 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Nucleus ABI541 Auditory Brainstem Implant — DEVICE
    Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device

Study Details

This study is a feasibility study of the Nucleus 24 ABI in children without NF2. It will be conducted as a repeated-measures, single subject experiment in order to accommodate the known variability in cochlear implant clinical results. Data obtained in the course of this study will be compared with the existing published outcome data from children with normal hearing and with cochlear implants (CIs). These comparisons may provide additional useful information about the progress of ABI subjects' performance over time. Also, this may allow the results of the current study to be utilized to design future pivotal studies of the device in the pediatric population.

Key Dates

Start date
May 31, 2014
Status verified
Oct 2025
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-lingual Deafness
    Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in prelingiustically deaf children ages 18 months - 5 years
  • Experimental: Post-Lingual Deafness
    Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant in postlinguistically deaf children \< 21 years of age

Primary Outcome Measure

ABI Device Complications [ Time Frame: 5 Years from date of surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Cochlear Implant CenterNew YorkNew York10016
Kristin Montella
[email protected]
212-263-8182
John T. Roland, MD (PRINCIPAL_INVESTIGATOR)
Susan B. Waltzman, PhD (SUB_INVESTIGATOR)

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By research site
NYU Cochlear Implant Center· New York, NY

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